Laser Link HS

GUDID 00810096330338

Lumenis Be, Inc.

Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor Laser adaptor

• Primary Device ID: 00810096330338
• NIH Device Record Key: c1c40fd0-51ef-446c-b231-4a10594c6337
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laser Link HS
• Version Model Number: Laser Link HS 532nm
• Company DUNS: 118292380
• Company Name: Lumenis Be, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810096330338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151109

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-10
• Device Publish Date: 2023-04-02

On-Brand Devices [Laser Link HS]

• 00810096330338: Laser Link HS 532nm
• 00810096330321: Laser Link HS 532/577/659nm